Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NNC0487-0111 (formulation D), NNC0487-0111 oral
NNC0487-0111 · 19 trials · 8 indications
Measured as percentage of body weight (%).
Measured in days.
Measured in days.
Measured as events/hour.
WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.
Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis- related disability.
Number of events
Number of events
Measured in kilojoules per day (kJ/day)
Measured as hours\*nanomole per liter (nmol\*h/L)
Measured as milligram per minute per kilogram (mg/min/kg)
Measured as percentage change of energy.
Measured as percentage change of energy.
Measured as percentage change of energy.
Number of events
Measured as hours\*nanomole per liter (h\*nmol/L).
Measured as hours\*nanomoles per liter (h\*nmol/L)
Number of events
| Arm | Type | Description |
|---|---|---|
| NNC0487-0111 | EXPERIMENTAL | Participants will receive NNC0487-0111 administered subcutaneously once weekly with one of four dose levels as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 Placebo | PLACEBO_COMPARATOR | Participants will receive placebo administered subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to NNC0487-011 s.c. once weekly. |
| NNC0487-0111 dose level 1 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 2 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 3 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 4 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Low Energy Diet (LED) | OTHER | Participants will receive a low-energy dietary designed to achieve a reduction in body weight. |
| Severe hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Moderate hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Mild hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Normal hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| NNC0487-0111 (dose 1) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 2) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 3) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| Mild Renal Impairment | EXPERIMENTAL | Participants with mild renal impairment (estimated glomerular filtration rate \[eGFR\] - 60 - 89 milliliter per min \[mL/min\]) will administer a single dose of NNC0487-0111 on Day 1. |
| Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1. |
| Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1. |
| End-Stage Renal Disease (ESRD) | EXPERIMENTAL | Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1. |
| Normal Renal Function | EXPERIMENTAL | Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1. |
| Phase A: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase A: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase B: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D). |
| Phase B: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C). |
| Name | Type | Description |
|---|---|---|
| NNC0487-0111 | DRUG | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to NNC0487-0111) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to semaglutide) | DRUG | Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo | DRUG | Placebo (matched to NNC0487-011) will be administered subcutaneously. |
| Placebo (matched to NNC0487-0111 ) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (NNC0487-0111) | DRUG | Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. |
| LED | BEHAVIORAL | A meal plan and meal replacements will be provided by the investigators. |
| NNC0487-0111 (formulation D) | DRUG | Participants will receive NNC0487-0111 (formulation D) tablet once daily. |
| NNC0487-0111 (formulation C) | DRUG | Participants will receive NNC0487-0111 (formulation C) tablet once daily. |
Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * For participants with T2D at screening (max 25%), the following inclusion criteria apply * Diagnosed with T2D ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7.0 -10.0%...
NNC0487-0111 is an investigational oral small molecule developed by Novo Nordisk A/S for the treatment of type 2 diabetes, obesity, and overweight. It is currently in Phase 3 clinical development, with additional Phase 1 studies ongoing. It has not been approved by any regulatory agency.
NNC0487-0111 is being studied for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight. Phase 3 trials are also evaluating it in people with excess body weight and obstructive sleep apnoea. It remains investigational and is not approved for any indication.
NNC0487-0111 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical trial program, which includes 12 trials in total across Phase 1 and Phase 3.
NNC0487-0111 is in Phase 3 clinical development. The program includes 12 trials overall, with 9 currently active and 3 completed. The Phase 3 studies are randomized, double-blind, and placebo-controlled, and the drug is not yet approved.
NNC0487-0111 is being evaluated in multiple trials, including the Phase 3 AMAZE 10 study (NCT07822061) in Japan for overweight and obesity, the Phase 3 AMAZE 4 study (NCT07571109) in obesity with obstructive sleep apnoea, and Phase 1 studies NCT07757087 and NCT07587710.
Yes. NNC0487-0111 (formulation D) and NNC0487-0111 oral are alternative names for the same investigational drug, NNC0487-0111, developed by Novo Nordisk A/S. The oral designation reflects its small molecule oral formulation.